# K083305: Powder Free Nitrile Examination Gloves, Sterile with Chemotherapy Claim

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Jun 18, 2009 after 220 days
- Product code: LZC (Medical Glove, Specialty)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K993313 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993313: Comfit Powder Free Blue Nitrile Examination Glove, Sterile, Wrp Asia Pacific Sdn. Bhd. (1999) Summary page 1.

## Indications for use
The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested, for use with chemotherapy drugs. Tested chemotherapy drugs are as follows [Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride; 5-Fluorouracil, Cisplatin, Etoposide, Vincristine Sulfate and Paclitaxel] WARNING: DO NOT USE GLOVES WITH CARMUSTINE OR THIO-TEPA

Source page: https://510kreport.com/device/K083305
Methodology: https://510kreport.com/methodology